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Bepotastine besilateis the generic ingredient in two branded drugs marketed by Apotex, Mylan, and Bausch And Lomb Inc, and is included in three NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.
Bepotastine besilate has eleven patent family members in eight countries.
There are seven drug master file entries for bepotastine besilate. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for bepotastine besilate
|Drug Master File Entries:||7|
|Suppliers / Packagers:||1|
|Bulk Api Vendors:||63|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for bepotastine besilate|
|DailyMed Link:||bepotastine besilate at DailyMed|
Recent Clinical Trials for bepotastine besilate
Identify potential brand extensions & 505(b)(2) entrants
|Dong-A ST Co., Ltd.||N/A|
|Dong-A ST Co., Ltd.||Phase 1|
|Daewoong Pharmaceutical Co. LTD.||Phase 1|
Generic filers with tentative approvals for BEPOTASTINE BESILATE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for bepotastine besilate
|Drug Class||Histamine-1 Receptor Antagonist |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Mylan||BEPOTASTINE BESILATE||bepotastine besilate||SOLUTION/DROPS;OPHTHALMIC||206220-001||Mar 18, 2019||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Bausch And Lomb Inc||BEPREVE||bepotastine besilate||SOLUTION/DROPS;OPHTHALMIC||022288-001||Sep 8, 2009||RX||Yes||Yes||Start Trial||Start Trial||Y||Start Trial|
|Apotex||BEPOTASTINE BESILATE||bepotastine besilate||SOLUTION/DROPS;OPHTHALMIC||206066-001||Mar 5, 2019||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Bausch And Lomb Inc||BEPREVE||bepotastine besilate||SOLUTION/DROPS;OPHTHALMIC||022288-001||Sep 8, 2009||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
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